WO2014013591A1 - Dispositif de perforation - Google Patents

Dispositif de perforation Download PDF

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Publication number
WO2014013591A1
WO2014013591A1 PCT/JP2012/068361 JP2012068361W WO2014013591A1 WO 2014013591 A1 WO2014013591 A1 WO 2014013591A1 JP 2012068361 W JP2012068361 W JP 2012068361W WO 2014013591 A1 WO2014013591 A1 WO 2014013591A1
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WO
WIPO (PCT)
Prior art keywords
puncture needle
puncture
needle
tip
needle tip
Prior art date
Application number
PCT/JP2012/068361
Other languages
English (en)
Japanese (ja)
Inventor
政克 川浦
有浦　茂樹
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2012/068361 priority Critical patent/WO2014013591A1/fr
Publication of WO2014013591A1 publication Critical patent/WO2014013591A1/fr
Priority to US14/600,512 priority patent/US10258374B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/062—Needle manipulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06057—Double-armed sutures, i.e. sutures having a needle attached to each end

Definitions

  • the present invention relates to a puncture device.
  • Urinary incontinence particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc.
  • the cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
  • Surgical therapy is effective for the treatment of urinary incontinence.
  • a tape-like implant called “sling” is used, and the sling is placed in the body, and the urethra is supported by the sling (see, for example, Patent Document 1). ).
  • the surgeon incises the vagina wall with a scalpel, peels off the space between the urethra and the vagina, and uses the puncture needle to communicate the peeled site and the outside through the pelvic obturator. And a puncture hole is formed. Then, the sling is placed in the body using such a puncture hole.
  • vagina wall is incised, there is a risk that a sling may be exposed in the vagina from the wound created by the incision, and there may be complications such as infection from the wound. Further, since the vagina wall is incised, there is a disadvantage that the invasion is large and the burden on the patient is large. In addition, there is a possibility that the urethra and the like may be damaged with a scalpel during the procedure by the operator, and the operator himself may damage the fingertip with the scalpel.
  • An object of the present invention is to provide a puncture device that has a low patient burden, high patient safety, and high operator safety.
  • a first puncture needle having a first needle tip and puncturing a living tissue;
  • a shaft coupled to the first puncture needle;
  • a second needle tip, the second needle tip is oriented in a different direction from the first needle tip, and in a proximal direction of the first puncture needle with respect to the first puncture needle
  • a second puncture needle that is movably installed and punctures a living tissue;
  • a puncture apparatus comprising: a moving unit that moves the second puncture needle toward the proximal end of the first puncture needle with respect to the first puncture needle.
  • the first puncture needle has a hollow portion
  • the second puncture needle is inserted into the hollow portion so as to be movable relative to the first puncture needle along the longitudinal direction of the first puncture needle.
  • the puncture device according to any one of (3).
  • the puncture device having an opening communicating with the hollow portion of the first puncture needle in the vicinity of the connecting portion between the first puncture needle and the shaft;
  • the second puncture needle is configured to protrude from the opening when the second puncture needle is moved in the proximal direction of the first puncture needle with respect to the first puncture needle.
  • the second puncture needle has a hollow portion into which the first puncture needle is inserted in a state where the first needle tip protrudes from the second puncture needle, Any of the above (1) to (3), wherein the second puncture needle is installed to be movable relative to the first puncture needle along the longitudinal direction of the first puncture needle.
  • the puncture device according to any one of the above.
  • puncture device according to any one of (1) to (7), wherein the puncture device includes a filament that has one end connected to the first puncture needle and the other end connected to the second puncture needle.
  • the first puncture needle has a main body portion and the first needle tip that is detachably installed at a distal end portion of the main body portion,
  • each of the first puncture needle and the second puncture needle has a portion that is curved along a longitudinal direction thereof.
  • the puncture device according to any one of (1) to (12), further including a regulation unit that regulates a puncture direction of the first puncture needle.
  • FIG. 1 is a diagram showing a first embodiment of the puncture device of the present invention.
  • FIG. 2 is a perspective view showing a state in which the rear puncture needle of the puncture apparatus shown in FIG. 1 is protruded.
  • FIG. 3 is a perspective view showing the puncture device shown in FIG.
  • FIG. 4 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG.
  • FIG. 5 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG.
  • FIG. 6 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG.
  • FIG. 7 is a perspective view showing a second embodiment of the puncture apparatus of the present invention.
  • FIG. 8 is a side view showing a third embodiment of the puncture device of the present invention.
  • FIG. 9 is a side view showing a fourth embodiment of the puncture device of the present invention.
  • FIG. 10 is a view of the puncture device shown in FIG. 9 as seen from the direction of arrow B in FIG.
  • FIG. 11 is a side view showing a state where the rear puncture needle of the puncture apparatus shown in FIG. 9 is protruded.
  • FIG. 12 is a perspective view showing a guide device in the fifth embodiment of the puncture device of the present invention.
  • FIG. 13 is a diagram illustrating a usage example of the guide device illustrated in FIG. 12.
  • FIG. 1A and 1B are views showing a first embodiment of the puncture apparatus of the present invention
  • FIG. 1A is a perspective view
  • FIG. 1B is a view from the direction of arrow A in FIG. It is a figure.
  • FIG. 2 is a perspective view showing a state in which the rear puncture needle of the puncture apparatus shown in FIG. 1 is protruded.
  • FIG. 3 is a perspective view showing the puncture device shown in FIG. 4 to 6 are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIGS. 1, 2, and 4 to 6 are diagrams schematically showing the lengths of the front puncture needle, the rear puncture needle, and the shaft in FIGS. The thickness ratio is different from the actual one.
  • FIG. 3 shows an example of an actual puncture device.
  • the needle tip side of the front puncture needle is referred to as “tip” or “front”, and the side opposite to the needle tip is referred to as “base end” or “backward”. Will be described.
  • the needle tip side is the “tip” and the side opposite to the needle tip is the “base end”.
  • the needle tip side is the “tip”, and the side opposite to the needle tip is the “proximal end”.
  • the shaft in FIGS. In the following description, the left side is “tip” and the right side is “base”.
  • the puncture apparatus 1 shown in these drawings is an apparatus used when an urinary incontinence treatment for a woman, that is, an urinary incontinence treatment implant (in-vivo indwelling device) is embedded in a living body.
  • Implants are implantable devices for the treatment of urinary incontinence in women, i.e. devices that support the urethra, e.g. when the urethra is about to move toward the vaginal wall, it pulls the urethra away from the vaginal wall It is the instrument which supports in this way.
  • this implant for example, a long object having flexibility can be used.
  • the implant 8 has a net shape, and the entire shape thereof has a band shape.
  • This implant 8 is called a “sling”.
  • the implant 8 can be configured by, for example, a braided body in which a linear body is crossed and knitted in a net (lattice), that is, a net-like braid.
  • the linear body include a circular cross-sectional shape, a flat cross-sectional shape, that is, a belt-like (ribbon-like) shape.
  • One end of the thread 91 is fixed to one end of the implant 8, and one end of the thread 92 is fixed to the other end.
  • constituent material of the implant 8 is not particularly limited, and for example, various resin materials and fibers having biocompatibility such as polypropylene can be used.
  • constituent materials of the yarns 91 and 92 are not particularly limited, and various biocompatible resin materials such as polypropylene, fibers, and the like can be used, for example.
  • the implant 8 is not limited to the net-like one.
  • the puncture device 1 includes a front puncture needle (first puncture needle) 3 having a needle tip (first needle tip) 31 for puncturing a living tissue, a front puncture needle 3, A rear end having a needle tip (second needle tip) 41 that is installed so as to be relatively movable along the longitudinal shape of the front puncture needle 3 with respect to the connected shaft 2 and the front puncture needle 3.
  • a puncture needle (second puncture needle) 4 a wire (traction line) 5 as a moving means for moving the rear puncture needle 4 toward the proximal end of the front puncture needle 3 with respect to the front puncture needle 3, and a thread (filamentous body) 6).
  • the rear puncture needle 4 has its needle tip 41 oriented in a direction different from the needle tip 31 of the front puncture needle 3, and can move in the proximal direction of the front puncture needle 3, that is, the side opposite to the needle tip 31 of the front puncture needle 3. Is installed.
  • the front puncture needle 3 and the rear puncture needle 4 are respectively curved, and the rear puncture needle 4 extends along the curved axis of the front puncture needle 3.
  • Move in the proximal direction that is, in the present invention, “the rear puncture needle 4 moves in the proximal direction of the front puncture needle 3” includes not only the case where the rear puncture needle 4 moves on a straight line but also the case where it moves on a curve. It is.
  • the front puncture needle 3 has a main body portion 32 and a needle tip 31 that is detachably attached to the distal end portion of the main body portion 32 (removable).
  • the main body 32 has a tubular shape. And the main-body part 32 curves in the circular arc shape along the longitudinal direction, Furthermore, the base end part is curving in the direction different from the said circular arc, as shown in FIG.1 (b) and FIG. . Further, an opening 33 communicating with the hollow portion 34 of the main body portion 32 is formed in the vicinity of the connecting portion between the front puncture needle 3 and the shaft 2, in this embodiment, on the wall portion of the base end portion of the main body portion 32. .
  • a reduced diameter portion 311 having an outer diameter slightly smaller than the inner diameter of the main body portion 32 is formed at the proximal end portion of the needle tip 31.
  • the reduced diameter portion 311 is fitted to the distal end portion of the main body portion 32.
  • the rear puncture needle 4 has a main body portion 42 and a needle tip 41 fixed to the distal end portion of the main body portion 42.
  • the needle tip 41 and the main body 42 are formed integrally, for example.
  • the rear puncture needle 4 may be solid or may be a tubular hollow.
  • the main body 42 is curved in an arc along the longitudinal direction. Therefore, by puncturing a living tissue from the body surface near the urethra and vagina with the front puncture needle 3, the front puncture needle 3 can easily and reliably avoid the urethra wall and the vagina wall to avoid the urethra and vagina. Can be punctured with the living tissue between the two.
  • the radius of the arc of the main body 42 is set substantially equal to the radius of the arc of the main body 32 of the front puncture needle 3.
  • the outer diameter of the main body 42 is set smaller than the inner diameter of the main body 32 of the front puncture needle 3.
  • the rear puncture needle 4 is inserted in the hollow portion 34 of the front puncture needle 3 so as to be movable with respect to the front puncture needle 3 along the longitudinal direction of the front puncture needle 3 and detachable.
  • the rear puncture needle 4 When the rear puncture needle 4 is moved in the proximal direction of the front puncture needle 3 with respect to the front puncture needle 3, the rear puncture needle 4 projects to the outside from the opening 33 of the front puncture needle 3.
  • constituent materials of the front puncture needle 3 and the rear puncture needle 4 are not particularly limited, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like can be used.
  • the thread 6 is used when the implant 8 is embedded in the living body and the implant 8 is transferred into the living body.
  • One end of the thread 6 is connected to the needle tip 31 of the front puncture needle 3, and the other end is connected to the proximal end of the rear puncture needle 4.
  • the thread 6 is disposed outside the front puncture needle 3 and is inserted into the hollow portion 34 from the opening 33.
  • constituent material of the yarn 6 is not particularly limited, and for example, various resin materials, fibers, and the like can be used.
  • the shaft 2 has a tubular shape, and its tip is curved.
  • the distal end of the shaft 2 is connected to the proximal end of the front puncture needle 3, and the lumen of the shaft 2 communicates with the hollow portion 34 of the front puncture needle 3.
  • the constituent material of the shaft 2 is not particularly limited, and various resin materials, various metal materials, and the like can be used, for example.
  • the wire 5 is for pulling and moving the rear puncture needle 4 toward the needle tip side 41 with respect to the front puncture needle 3 and is detachably connected to the rear puncture needle 4.
  • a through hole 43 is formed in the proximal end portion of the rear puncture needle 4 (see FIG. 5B), and the wire 5 is folded in a state of being inserted through the through hole 43.
  • the shaft 2 is inserted. Both ends of the wire 5 protrude from the base end of the shaft 2 to the outside.
  • both ends of the wire 5 are gripped and pulled in the proximal direction of the shaft 2.
  • constituent material of the wire 5 is not particularly limited, and for example, stainless steel, a superelastic alloy such as a Ni—Ti alloy, or the like can be used.
  • the shaft 2 of the puncture device 1 is grasped, and more specifically, a site in the vicinity of the base of the patient's leg, more specifically, a site in the vicinity between the base of the leg (not shown) on the right side in FIG.
  • the needle tip 31 of the front puncture needle 3 is punctured from the body surface.
  • the shaft 2 is rotated clockwise in FIG.
  • the front puncture needle 3 is moved in the distal direction along the curved shape, and the front puncture needle 3
  • the needle tip 31 punctures a living tissue between the urethra (biological lumen) 100 and the vagina (biological lumen) 200, that is, the needle tip 31 passes between the urethra 100 and the vagina 200, and further, It passes through a closing hole (not shown) on the left side in FIG. 4A and protrudes from the body surface to the outside of the body.
  • the opening 33 is located on the right side in FIG. 4A with respect to the urethra 100 and the vagina 200 in a state where the needle tip 31 of the front puncture needle 3 protrudes from the body surface to the outside of the body. .
  • both ends of the wire 5 are gripped without moving the front puncture needle 3, and the wire 5 is pulled toward the proximal end of the shaft 2.
  • the rear puncture needle 4 moves along the longitudinal direction of the front puncture needle 3 in the distal direction of the rear puncture needle 4, that is, in the proximal direction of the front puncture needle 3. Passes through a closing hole (not shown) on the right side of the pelvis in FIG. 4B and protrudes from the body surface to the outside of the body.
  • the back puncture needle 4 is located on the inner peripheral side of the front puncture needle 3, the contact area between the back puncture needle 4 and the living tissue can be made relatively small, and the back puncture needle can be easily and smoothly performed.
  • the needle 4 can be moved, and the burden on the patient can be reduced.
  • a puncture hole 500 for embedding the implant 8 in the living body is formed in the patient.
  • the puncture hole 500 includes a left-side obstruction hole, a space between the urethra 100 and the vagina 200, and a right-side obstruction hole from the body surface of a not-shown buttocks on the left side in FIG. This is a through-hole that reaches the body surface of the buttocks not shown on the right side in FIG.
  • the opening 33 is located on the right side in FIG. 4A with respect to the urethra 100 and the vagina 200 with the needle tip 31 of the front puncture needle 3 protruding from the body surface to the outside of the body.
  • the opening 33 may be located on the left side in FIG. 4A from the urethra 100 and the vagina 200, or may be located between the urethra 100 and the vagina 200.
  • a living tissue between the vagina and the vagina 200 is punctured. That is, the needle tip 41 passes between the urethra 100 and the vagina 200, passes through a closing hole (not shown) on the right side of the pelvis in FIG. 4B, and protrudes from the body surface to the outside of the body.
  • the needle tip 31 of the front puncture needle 3 is gripped, the needle tip 31 is removed from the main body 32, and the rear puncture needle 4 is gripped, and the rear puncture needle 4 is moved in the proximal direction of the front puncture needle 3 to be detached from the front puncture needle 3 and removed from the patient.
  • the thread 6 in the vicinity of one of the needle tip 31 and the rear puncture needle 4 of the front puncture needle 3 is cut, and any of the thread 91 and the thread 92 on the implant 8 side is cut at the end of the thread 6. Tie one end together.
  • the thread 6 near the rear puncture needle 4 is cut, and the end of the thread 91 is tied to the end of the thread 6.
  • the needle tip 31 of the front puncture needle 3 protrudes from the body surface to the outside of the body, the needle tip 31 is removed from the main body 32, and the yarn near the needle tip 31 is removed. 6 may be cut, and the end of the yarn 6 on the side of the implant 8 may be tied to the end of the yarn 6.
  • the needle tip 31 of the front puncture needle 3 is grasped and pulled, and the implant 8 is inserted into the puncture hole 500 formed in the patient, and the right end of the implant 8 in FIG. 6 is pulled out of the body from the puncture hole 500.
  • the threads 91 and 92 are each pulled with a predetermined force, the position of the implant 8 with respect to the urethra 100 is adjusted, unnecessary portions of the implant 8 are excised, a predetermined treatment is performed, and the procedure is finished.
  • the puncture device 1 when the implant 8 is embedded in the living body, it can be handled only by a minimally invasive technique such as puncture of the front puncture needle 3 and the rear puncture needle 4. Since it is not necessary to perform a invasive incision or the like, the burden on the patient is small, and the safety of the patient is high.
  • the front puncture needle 3 and the rear puncture needle 4 are provided, when forming the puncture hole 500, the front puncture needle 3 punctures a biological tissue from the body surface in the vicinity between the urethra and the vagina, Furthermore, the puncture hole 500 can be formed by using the back puncture needle 4.
  • the front puncture needle 3 since the biological tissue is punctured from the body surface in the vicinity between the urethra and the vagina by the front puncture needle 3, the front puncture needle 3 avoids the urethra wall and the vagina wall and avoids the urethra and the vagina. Can puncture the living tissue between. That is, in this puncture device 1, it is possible to prevent puncture of the urethral wall and puncture of the vagina wall, and the puncture hole 500 can be formed safely and easily. .
  • the fingertip can be prevented from being damaged by a scalpel or the like, which is safe.
  • the puncture hole formed in the patient by the puncture needle is a through hole, but the puncture hole is not limited to this, and the non-through hole may be used.
  • the tip of the shaft 2 is curved.
  • the present invention is not limited to this.
  • the shaft 2 may be entirely linear.
  • each of the front puncture needle 3 and the rear puncture needle 4 may be, for example, a part of which is curved in an arc shape, or the whole of which is curved in an arc shape. May be. That is, each of the front puncture needle 3 and the rear puncture needle 4 only needs to have a portion that is curved in an arc shape at least at a part thereof. Further, the shapes of the curved portions of the front puncture needle 3 and the rear puncture needle 4 are not limited to arc shapes, respectively.
  • FIG. 7 is a perspective view showing a second embodiment of the puncture apparatus of the present invention.
  • FIG. 7B for the sake of easy understanding, diagonal lines in the living body are omitted, and a thread is inserted into the closed hole.
  • FIG. 7 is a diagram schematically showing that in FIG. 7, the ratio of length to thickness is different from the actual ratio in the front puncture needle, the rear puncture needle and the shaft.
  • the needle tip side of the front puncture needle is referred to as “tip” or “front”, and the side opposite to the needle tip is referred to as “base end” or “backward”,
  • the needle tip side is the “tip”
  • the opposite side of the needle tip is the “base end”
  • the needle tip side is the “tip”
  • the side opposite to the needle tip is the “proximal end”
  • the shaft is along the longitudinal direction of the shaft in FIG. 7.
  • the left side is “tip” and the right side is “base end”.
  • the puncture device 1 of the second embodiment has a long shape instead of the wire 5 as the moving means, and presses the posterior puncture needle 4 toward the needle tip 41 side.
  • a pusher (pressing member) 7 to be moved is provided.
  • the pusher 7 has such flexibility that it can be elastically deformed so as to conform to the shape of the front puncture needle 3 and rigidity that allows the rear puncture needle 4 to be pressed and moved.
  • the pusher 7 When moving the back puncture needle 4 using the pusher 7, as shown in FIG. 7 (b), the pusher 7 is inserted into the hollow portion 34 from the opening of the front end of the main body 32 of the front puncture needle 3, Push forward.
  • the rear puncture needle 4 is pressed by the pusher 7 and moves in the distal direction of the rear puncture needle 4 along the longitudinal direction of the front puncture needle 3, that is, the proximal direction of the front puncture needle 3.
  • the needle tip 41 of the puncture needle 4 passes through a closing hole (not shown) on the right side of the pelvis in FIG. 7B and protrudes from the body surface to the outside of the body.
  • FIG. 8 is a side view showing a third embodiment of the puncture device of the present invention.
  • FIG. 8 is a diagram schematically showing that in FIG. 8, the ratio of length to thickness is different from the actual ratio in the front puncture needle, the rear puncture needle, and the shaft.
  • the front puncture needle 3 is not curved except for the proximal end portion, and is linear. Further, the rear puncture needle 4 is not curved but has a straight shape. According to this puncture device 1, the same effect as the first embodiment described above can be obtained.
  • the third embodiment can also be applied to the second embodiment described above and the fifth embodiment described later.
  • FIG. 9 is a side view showing a fourth embodiment of the puncture device of the present invention.
  • FIG. 10 is a view of the puncture device shown in FIG. 9 as seen from the direction of arrow B in FIG.
  • FIG. 11 is a side view showing a state where the rear puncture needle of the puncture apparatus shown in FIG. 9 is protruded.
  • 9 to 11 are diagrams schematically showing the ratios of length and thickness in the front puncture needle, the rear puncture needle and the shaft in FIGS. 9 to 11. .
  • the needle tip side of the front puncture needle is referred to as “tip” or “front”, and the side opposite to the needle tip is “base end” or “backward”
  • the needle tip side is the “tip”
  • the side opposite to the needle tip is the “base end”.
  • the needle tip side is the “tip”
  • the side opposite to the needle tip is the “proximal end”.
  • the rear puncture needle 4 has a tubular shape.
  • the front puncture needle 3 is inserted into the hollow portion 45 of the rear puncture needle 4 with the needle tip 31 protruding outside from the proximal end of the rear puncture needle 4.
  • the front puncture needle 3 is inserted into the hollow portion 45 of the rear puncture needle 4 so as to be movable relative to the rear puncture needle 4 along the longitudinal direction of the rear puncture needle 4. That is, the back puncture needle 4 is installed on the outer peripheral surface of the front puncture needle 3 so as to be movable along the longitudinal direction of the front puncture needle 3 and detachable.
  • the main body portion 32 of the front puncture needle 3 has a curved portion 35 having a plate shape at the proximal end portion, and the proximal end of the curved portion 35 and the distal end of the shaft 2 are connected.
  • the curved portion 35 is formed such that the width in the direction perpendicular to the paper surface of FIG. 9, that is, the width W1 in FIG. 10 is smaller than the width W2 in the vertical direction in FIG.
  • the width W1 of the bending portion 35 is smaller than the diameter of the main body portion 32 on the distal end side from the bending portion 35, and the width W2 of the bending portion 35 is equal to the diameter of the main body portion 32 on the distal end side from the bending portion 35.
  • the back puncture needle 4 has the slit 44 formed along the axial direction in the upper right side in FIG.
  • the slit 44 is formed from the distal end to the proximal end of the rear puncture needle 4. That is, the slit 44 is open to the proximal end and the distal end of the rear puncture needle 4.
  • the width of the slit 44 in the direction perpendicular to the paper surface of FIG. 9 is set to be larger than the width W1 of the curved portion 35.
  • the fourth embodiment can also be applied to the first and second embodiments described above and a fifth embodiment described later.
  • FIG. 12 is a perspective view showing a guide device in the fifth embodiment of the puncture device of the present invention.
  • FIG. 13 is a diagram illustrating a usage example of the guide device illustrated in FIG. 12.
  • FIG. 12 and FIG. 13 are diagrams schematically, and in FIG. 12 and FIG. 13, the ratio between the length and the thickness of the urethra insertion part and the vaginal insertion part is different from the actual ratio.
  • the left side of FIGS. 12 and 13 is referred to as the “tip” and the right side is referred to as the “base end”.
  • the puncture device 1 of the fifth embodiment further includes a guide device 11 as a restriction means for regulating the puncture directions of the front puncture needle 3 and the rear puncture needle 4.
  • the guide device 11 includes a guide device body 12 and a guide member 13.
  • the guide device body 12 includes a longitudinal urethral insertion portion 14 that is inserted into the urethra, a longitudinal vagina insertion portion 15 that is inserted into the vagina, a pair of guide plates 16 and 17, and a urethral insertion portion 14. And a support portion 18 that supports the vaginal insertion portion 15.
  • the guide plates 16 and 17 are flat plates and are arranged so as to be parallel to each other with a predetermined distance therebetween.
  • the guide plate 16 is located above the guide plate 17 in FIG.
  • the shapes of the guide plates 16 and 17 are not particularly limited, but are rectangular in the present embodiment.
  • the support portions 18 are fixed to predetermined end surfaces of the guide plates 16 and 17, so that the guide plates 16 and 17 are held at a predetermined distance from each other.
  • the urethral insertion portion 14 is fixed to a position corresponding to the guide plate 16 of the support portion 18.
  • the urethral insertion portion 14 has a straight bar shape made of a non-flexible hard material, and is arranged so that the axis thereof and the guide plate 16 are parallel to each other. Further, the distal end portion of the urethral insertion portion 14 is rounded. Thereby, the urethral insertion part 14 can be smoothly inserted into the urethra.
  • the vaginal insertion portion 15 is fixed at a position corresponding to the guide plate 17 of the support portion 18.
  • the vaginal insertion portion 15 has a straight bar shape, and is arranged so that the axis thereof and the guide plate 18 are parallel to each other. Note that the axis of the vaginal insertion portion 15 and the axis of the urethral insertion portion 14 are parallel. In addition, the distal end portion of the vaginal insertion portion 15 is rounded. Thereby, the vagina insertion part 15 can be smoothly inserted in the vagina.
  • the separation distance between the guide plate 16 and the guide plate 17 of the guide device main body 12 and the separation distance between the urethral insertion portion 14 and the vaginal insertion portion 15 are equal. Therefore, when the urethra insertion part 14 is inserted into the urethra and the vagina insertion part 15 is inserted into the vagina, the space between the guide plate 16 and the guide plate 17 corresponds to the space between the urethra and the vagina.
  • the guide member 13 has a rectangular parallelepiped shape, and a through hole 131 is formed in the guide member 13.
  • the guide member 13 is used with the shaft 2 inserted into the through hole 131.
  • the height L of the guide member 13 is set to be approximately equal to or slightly smaller than the separation distance between the guide plate 16 and the guide plate 17.
  • the guide member 13 is used by being inserted between a guide plate 16 and a guide plate 17 as shown in FIG.
  • the constituent materials of the urethral insertion portion 14, the vagina insertion portion 15, the guide plates 16, 17, the support portion 18, and the guide member 13 are not particularly limited, and various resin materials can be used, for example.
  • the shaft 2 When using the guide device 11, the shaft 2 is inserted into the through hole 131 of the guide member 13, and the guide member 13 is inserted between the guide plate 16 and the guide plate 17. Then, the shaft 2 is moved together with the guide member 13, or the guide member 13 is fixed to the guide plates 16 and 17, and the shaft 2 is moved using the through hole 131 as a guide, or these are used together. As a result, the front side puncture needle 3 and the rear side puncture needle 4 each move within a corresponding range between the guide plate 16 and the guide plate 17, and the front side puncture needle 3 and the rear side puncture needle 4 are It is possible to prevent puncture of the urethral wall and the vagina wall.
  • the present invention may be a combination of any two or more configurations of the above embodiments.
  • the cross-sectional shape of the inner peripheral surface of the front puncture needle and the cross-sectional shape of the outer peripheral surface of the rear puncture needle may be non-circular, for example. Thereby, it is possible to prevent the rear puncture needle from rotating about the axis with respect to the front puncture needle.
  • the said embodiment demonstrated the case where the puncture apparatus of this invention was applied to the apparatus used when implanting the implantable implant for the treatment of female urinary incontinence in the living body, the puncture apparatus of this invention was demonstrated.
  • the use of is not limited thereto.
  • the burden on the patient is small, the safety of the patient is high, and the safety of the operator is also high.
  • the puncture device of the present invention when used for the treatment of urinary incontinence in women, when an implant for the treatment of urinary incontinence is embedded, the incision of the vagina wall is unnecessary, and the implant is embedded by a minimally invasive procedure. can do.
  • the front puncture needle punctures a living tissue from the body surface near the urethra and vagina.
  • the puncture hole can be formed by using a rear puncture needle.
  • the living tissue is punctured from the body surface in the vicinity between the urethra and vagina with the front puncture needle, and the urethra and vagina are avoided by the front puncture needle, avoiding the urethra wall and vagina wall. Can puncture the living tissue between.

Abstract

La présente invention concerne un dispositif (1) de perforation doté : d'une aiguille (2) de perforation avant qui a une extrémité (31) d'aiguille avec laquelle un tissu d'organisme vivant est perforé ; d'une gaine (2) qui est reliée à l'aiguille (3) de perforation avant ; d'une aiguille (4) de perforation arrière qui est disposée pour être relativement mobile par rapport à l'aiguille (3) de perforation avant le long de la forme allongée de l'aiguille (3) de perforation avant et présente une extrémité (41) d'aiguille avec laquelle le tissu d'organisme vivant est perforé ; d'un fil métallique (5) qui déplace l'aiguille (4) de perforation arrière vers l'extrémité de base de l'aiguille (3) de perforation avant par rapport à l'aiguille (3) de perforation avant ; et d'un fil (6). L'aiguille (4) de perforation arrière est située pour être mobile vers l'extrémité de base de l'aiguille (3) de perforation avant, et son extrémité (41) d'aiguille fait face à une direction différente de celle de l'extrémité (31) d'aiguille de l'aiguille (3) de perforation avant. Le fil (6) est utilisé quand un implant est transféré dans un organisme vivant quand l'implant est incorporé dans l'organisme vivant, et une extrémité du fil (6) est reliée à l'extrémité (31) d'aiguille de l'aiguille (3) de perforation avant, et l'autre extrémité est reliée à l'extrémité de base de l'aiguille (4) de perforation arrière.
PCT/JP2012/068361 2012-07-19 2012-07-19 Dispositif de perforation WO2014013591A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/JP2012/068361 WO2014013591A1 (fr) 2012-07-19 2012-07-19 Dispositif de perforation
US14/600,512 US10258374B2 (en) 2012-07-19 2015-01-20 Puncture apparatus

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2012/068361 WO2014013591A1 (fr) 2012-07-19 2012-07-19 Dispositif de perforation

Related Child Applications (1)

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US14/600,512 Continuation US10258374B2 (en) 2012-07-19 2015-01-20 Puncture apparatus

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WO2014013591A1 true WO2014013591A1 (fr) 2014-01-23

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WO (1) WO2014013591A1 (fr)

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US10792036B2 (en) * 2017-11-15 2020-10-06 Winter Innovations, Llc Method and apparatus for double loop stitching
CN109589160A (zh) * 2018-12-10 2019-04-09 杭州德柯医疗科技有限公司 穿刺针及其穿刺装置
USD938031S1 (en) * 2019-07-14 2021-12-07 Telma Micro Needles Pvt. Ltd. Undrilled needle
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USD912251S1 (en) 2019-08-13 2021-03-02 Ethicon, Inc. Suture needle having a wave shape
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CN114366253B (zh) * 2022-03-01 2023-09-01 中国人民解放军陆军特色医学中心 一种具有便于清洗功能的肝胆科用穿刺装置

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US10258374B2 (en) 2019-04-16

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